Petition to retire the surviving sepsis campaign guidelines

Concern regarding the Surviving Sepsis Campaign (SSC) guidelines dates back to their inception. Guideline development was sponsored by Eli Lilly and Edwards Life Sciences as part of a commercial marketing campaign (1). Throughout its history, the SSC has a track record of conflicts of interest, making strong recommendations based on weak evidence, and being poorly responsive to new evidence (2-6).

The original backbone of the guidelines was a single-center trial by Rivers defining a protocol for early goal-directed therapy (7). Even after key elements of the Rivers protocol were disproven, the SSC continued to recommend them. For example, SSC continued to recommend the use of central venous pressure and mixed venous oxygen saturation after the emergence of evidence that they were nonbeneficial (including the PROCESS and ARISE trials). These interventions eventually fell out of favor, despite the slow response of SSC that delayed knowledge translation.

SSC has been sponsored by Eli Lilly, manufacturer of Activated Protein C. The guidelines continued recommending Activated Protein C until it was pulled from international markets in 2011. For example, the 2008 Guidelines recommended this, despite ongoing controversy and the emergence of neutral trials at that time (8,9). Notably, 11 of 24 guideline authors had financial conflicts of interest with Eli Lilly (10).

The Infectious Disease Society of America (IDSA) refused to endorse the SSC because of a suboptimal rating system and industry sponsorship (1). The IDSA has enormous experience in treating infection and creating guidelines. Septic patients deserve a set of guidelines that meet the IDSA standards.

Guidelines should summarize evidence and provide recommendations to clinicians. Unfortunately, the SSC doesn’t seem to trust clinicians to exercise judgement. The guidelines infantilize clinicians by prescribing a rigid set of bundles which mandate specific interventions within fixed time frames (example above). These recommendations are mostly arbitrary and unsupported by evidence (11,12). Nonetheless, they have been adopted by the Centers for Medicare & Medicaid Services as a core measure (SEP-1). This pressures physicians to administer treatments despite their best medical judgment (e.g. fluid bolus for a patient with clinically obvious volume overload).

We have attempted to discuss these issues with the SSC in a variety of forums, ranging from personal communications to formal publications (13-15). We have tried to illuminate deficiencies in the SSC bundles and the consequent SEP-1 core measures. Our arguments have fallen on deaf ears.

We have waited patiently for years in hopes that the guidelines would improve, but they have not. The 2018 SSC update is actually worse than prior guidelines, requiring the initiation of antibiotics and 30 cc/kg fluid bolus within merely sixty minutes of emergency department triage (16). These recommendations are arbitrary and dangerous. They will likely cause hasty management decisions, inappropriate fluid administration, and indiscriminate use of broad-spectrum antibiotics. We have been down this path before with other guidelines that required antibiotics for pneumonia within four hours, a recommendation that harmed patients and was eventually withdrawn (17).

It is increasingly clear that the SSC guidelines are an impediment to providing the best possible care to our septic patients. The rigid framework mandated by SSC doesn’t help experienced clinicians provide tailored therapy to their patients. Furthermore, the hegemony of these guidelines prevents other societies from developing better guidelines.

We are therefore petitioning for the retirement of the SSC guidelines. In its place, we would call for the development of separate sepsis guidelines by the United States, Europe, ANZICS, and likely other locales as well. There has been a monopoly on sepsis guidelines for too long, leading to stagnation and dogmatism. We would hope that these new guidelines are written by collaborations of the appropriate professional societies, based on the highest evidentiary standards. The existence of several competing sepsis guidelines could promote a diversity of opinions, regional adaptation, and flexible thinking about different approaches to sepsis.

We are disseminating an international petition that will allow clinicians to express their displeasure and concern over these guidelines. If you believe that our septic patients deserve more evidence-based guidelines, please stand with us.

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Comment Here

Great work folks, please keep this up. As an out of hospital critical care provider working in transport, we regularly see interfacility rescues necessitated by SSC. Now, these fallacies are dripping all the way down to prehospital providers in some cases- mandating they start SSC with their mere assessment of vital signs. In a world where critical thinking is being sucked out of medicine everywhere you turn, we have to take a stand.

[…] more than 20 academic physicians and thought leaders (including Dr. Paul Marik) have co-signed a statement strongly criticizing the Surviving Sepsis Campaign and its guidelines. An online petition has […]

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8 months ago

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Matthew Langston

Glad to hear this being discussed and I wholeheartedly agree. Martin Tobin [of the Tobin Index (RSBI)] was giving lectures about the influence of Big Pharma some ~10 yrs ago with Surviving Sepsis as a primary case study. At the time, he was viewed by many as needlessly contrarian and antiquated in his concern, but cogent thinking will never go out of style.

These conversations are so key in this day and age of quality metrics (VAP, CAUTI, etc etc etc)– well intentioned but potentially harmful especially when reimbursement is linked to questionable standards. Frontline clinicians need to have a voice

Totally agree with the retirement of these guidelines. They have led to inappropriate use of antibiotics in haste, departments have been penalised and resources misdirected.

What's Your Job?

Consultant EM

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8 months ago

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Tim Baptist

Never loved the guidelines but I still think they have saved lives and increased sepsis awareness. They also help with medical education—each recommendation can be looked at individually and the reasoning and controversy behind each recommendation can be discussed with the learner. Would like to see new guidelines made before we retire the old.

yep, the most realistic scenario for how to replace the SSC guidelines is as follows:

1. People realize that the SSC guidelines are bad, This creates a power vacuum.
2. A critical care society creates guidelines that are better than SSC (e.g. Canadian Sepsis Guidelines).
3. It is widely recognized that the new guidelines are a big improvement compared to the old SSC guidelines.
4. SSC guidelines continue to lose traction and influence.
5. Other societies stop endorsing the SSC guidelines. Some of these societies may make their own guidelines.

What's Your Job?

intensivist

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8 months ago

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tom fiero

thank you , Josh.
i find all this, all these conversations, regarding sepsis quite interesting.
the sides taken, the strong feelings regarding what is the perceived “truth”.
they are for the most part, i think, serious considerations by serious people who are striving for a better treatment plan, and results.
what is interesting too are the differences of opinion and understanding of definitions, and plans for behavior/treatment. who is making these?
what is sepsis? shock? what is the role of SIRS, qSofa? what is the value of lactic acid? what numbers are “important”?
it was recently mentioned at our ED dept meeting that “sepsis alerts” might start to be called in the field, and, i think, fluid boluses of 30ml/kg begun pre-hospital.
that would be interesting, wouldn’t it dr malik?
thank you, Josh.

I don’t think anyone knows the perfect way to manage these patients, I certainly don’t claim to. In the midst of this uncertainty, we need guidelines & regs that reflect how heterogeneous and dynamic these patients are.

What's Your Job?

intensivist

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8 months ago

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John Tiu

Thanks for doing this. This area has been crying for leadership for a while now.
I think we also ought to express our displeasure separately to the CMMS about the SEP-1 bundle mandates.

What's Your Job?

Pulm/CCM

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8 months ago

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Gerold Kretschmar

Thank you. To be honest, I did not know that the SSC were industry sponsored. As you mention above, every patient deserves a tailored approach. It isn’t even difficult to do that. I’ve got the feeling that the root of many strict guidelines is ATLS. (I know I am a little bit thought incongruent now). But even that system does not really work in clinical practice. What would be an alternative? We need something. As much Rivers EGDT is criticized, it woke up many of us and gave us an incentive to think sepsis.
Yes, SSC is flawed, yes it should be replaced. With what? Some kind of guidance is needed, but it should be flexible, easily updatable and user friendly.

What's Your Job?

Rural ED doc

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8 months ago

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Alex RN/CCRN-K

Has EMCrit discussed/posted regarding their take on the publication from the NYS department of Health study: “Time to Treatment and Mortality during Mandated Emergency Care for Sepsis”? I would love to see a review of the study, since this study is the basis of the new SSC 2018 update. Thanks.